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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00383188




Registration number
NCT00383188
Ethics application status
Date submitted
28/09/2006
Date registered
2/10/2006

Titles & IDs
Public title
An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis
Scientific title
A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH 797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS
Secondary ID [1] 0 0
2006-003577-27
Secondary ID [2] 0 0
A6631007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - placebo
Treatment: Drugs - PH-797804
Treatment: Drugs - PH-797804
Treatment: Drugs - PH-797804
Treatment: Drugs - PH-797804

Placebo comparator: 1 -

Experimental: 2 -

Experimental: 3 -

Experimental: 4 -

Experimental: 5 -


Treatment: Drugs: placebo
Capsule, once daily (QD) for 12 weeks

Treatment: Drugs: PH-797804
Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks

Treatment: Drugs: PH-797804
Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks

Treatment: Drugs: PH-797804
Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks

Treatment: Drugs: PH-797804
Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) (ACR 20) Response at Weeks 1, 2, 4, 8 and 16
Timepoint [1] 0 0
Weeks 1, 2, 4, 8, 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving American College of Rheumatology 50 Percent (%) (ACR 50) Response at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [2] 0 0
Weeks 1, 2, 4, 8, 12 and 16
Secondary outcome [3] 0 0
Percentage of Participants Achieving American College of Rheumatology 70 Percent (%) (ACR 70) Response at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [3] 0 0
Weeks 1, 2, 4, 8, 12 and 16
Secondary outcome [4] 0 0
Change From Baseline in Tender/Painful Joint Count at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [4] 0 0
Baseline, Weeks 1, 2, 4, 8, 12 and 16
Secondary outcome [5] 0 0
Change From Baseline in Swollen Joint Count at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [5] 0 0
Baseline, Weeks 1, 2, 4, 8, 12 and 16
Secondary outcome [6] 0 0
Change From Baseline in Participant Assessment of Arthritis Pain at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [6] 0 0
Baseline, Weeks 1, 2, 4, 8, 12 and 16
Secondary outcome [7] 0 0
Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Weeks 1, 2, 4, 8 12 and 16
Timepoint [7] 0 0
Baseline, Week 1, 2, 4, 8, 12 and 16
Secondary outcome [8] 0 0
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [8] 0 0
Baseline, Week 1, 2, 4, 8, 12 and 16
Secondary outcome [9] 0 0
Change From Baseline in C-Reactive Protein (CRP) at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [9] 0 0
Baseline, Week 1, 2, 4, 8, 12 and 16
Secondary outcome [10] 0 0
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4 [CRP]) at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [10] 0 0
Baseline, Weeks 1, 2, 4, 8, 12 and 16
Secondary outcome [11] 0 0
Number of Participants Who Withdrew From Study Due to Lack of Efficacy
Timepoint [11] 0 0
Baseline up to Week 16
Secondary outcome [12] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 1, 2, 4, 8, 12 and 16
Timepoint [12] 0 0
Baseline, Week 1, 2, 4, 8, 12 and 16
Secondary outcome [13] 0 0
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-SF) Score at Weeks 1, 2, 4, 8 and 12
Timepoint [13] 0 0
Baseline, Week 1, 2, 4, 8 and 12
Secondary outcome [14] 0 0
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2 at Weeks 4 and 12
Timepoint [14] 0 0
Baseline, Weeks 4, 12
Secondary outcome [15] 0 0
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [15] 0 0
Baseline up to Week 16
Secondary outcome [16] 0 0
Number of Participants With Laboratory Abnormalities
Timepoint [16] 0 0
Baseline up to Week 16
Secondary outcome [17] 0 0
Number of Participants With Clinically Significant Vital Signs Abnormalities
Timepoint [17] 0 0
Baseline up to Week 16
Secondary outcome [18] 0 0
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters
Timepoint [18] 0 0
Baseline up to Week 16
Secondary outcome [19] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities
Timepoint [19] 0 0
Baseline up to Week 16
Secondary outcome [20] 0 0
Number of Participants With Clinically Significant Physical Examination Abnormalities
Timepoint [20] 0 0
Baseline up to Week 16
Secondary outcome [21] 0 0
Minimum Observed Plasma Pre-dose Concentration (Ctrough Min) of Steady State
Timepoint [21] 0 0
Predose
Secondary outcome [22] 0 0
Number of Participants With Concomitant Medications
Timepoint [22] 0 0
Baseline up to Week 16

Eligibility
Key inclusion criteria
* Diagnosed with RA and has failed at least 1 DMARD therapy
Minimum age
19 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/07/2008
Sample size
Target
Accrual to date
Final
305
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Emeritus Research - Malvern East
Recruitment postcode(s) [1] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Paraná
Country [2] 0 0
Brazil
State/province [2] 0 0
PR
Country [3] 0 0
Brazil
State/province [3] 0 0
SP
Country [4] 0 0
Chile
State/province [4] 0 0
RM
Country [5] 0 0
Chile
State/province [5] 0 0
V Region
Country [6] 0 0
Chile
State/province [6] 0 0
VI Región
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Olomouc
Country [9] 0 0
Czechia
State/province [9] 0 0
Ostrava - Trebovice
Country [10] 0 0
Czechia
State/province [10] 0 0
Praha 2
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 4
Country [12] 0 0
Czechia
State/province [12] 0 0
Zlin
Country [13] 0 0
Estonia
State/province [13] 0 0
Tallinn
Country [14] 0 0
India
State/province [14] 0 0
Andhra Pradesh
Country [15] 0 0
India
State/province [15] 0 0
Karnataka
Country [16] 0 0
India
State/province [16] 0 0
Maharashtra
Country [17] 0 0
India
State/province [17] 0 0
Punjab
Country [18] 0 0
India
State/province [18] 0 0
Tamil NADU
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Anyang
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Peru
State/province [21] 0 0
Lima
Country [22] 0 0
Poland
State/province [22] 0 0
Bialystok
Country [23] 0 0
Poland
State/province [23] 0 0
Poznan
Country [24] 0 0
Poland
State/province [24] 0 0
Warszawa
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Moscow
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Smolensk
Country [27] 0 0
Russian Federation
State/province [27] 0 0
St. Petersburg
Country [28] 0 0
South Africa
State/province [28] 0 0
Gauteng
Country [29] 0 0
South Africa
State/province [29] 0 0
Johannesburg
Country [30] 0 0
South Africa
State/province [30] 0 0
Bloemfontein
Country [31] 0 0
South Africa
State/province [31] 0 0
Durban
Country [32] 0 0
South Africa
State/province [32] 0 0
Kempton Park
Country [33] 0 0
South Africa
State/province [33] 0 0
Pretoria
Country [34] 0 0
Spain
State/province [34] 0 0
Vizcaya
Country [35] 0 0
Spain
State/province [35] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00383188